Well Lead All Silicone Foley Catheter With Temperature Sensor

Catheter, Retention Type, Balloon

Well Lead Medical Co., LTD.

The following data is part of a premarket notification filed by Well Lead Medical Co., Ltd. with the FDA for Well Lead All Silicone Foley Catheter With Temperature Sensor.

Pre-market Notification Details

Device IDK202134
510k NumberK202134
Device Name:Well Lead All Silicone Foley Catheter With Temperature Sensor
ClassificationCatheter, Retention Type, Balloon
Applicant Well Lead Medical Co., LTD. C-4# Jinhu Industrial Estate, Hualong, Panyu Guangzhou,  CN 511434
ContactJenny Zhu
CorrespondentJenny Zhu
Well Lead Medical Co., LTD. C-4# Jinhu Industrial Estate, Hualong, Panyu Guangzhou,  CN 511434
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-31
Decision Date2021-04-08

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